FDA Ephedra Ban To Start

Apr 15, 2004 | Penn State Digital Collegian

A federal judge turned aside a request by two supplement makers and allowed a nationwide ban, which takes effect Monday, on dietary supplements containing Ephedra. The Ephedra ban is the first the FDA imposed on a dietary supplement.

U.S. District Judge Joel Pisano refused to grant two supplement makers a restraining order that would have prevented the Food and Drug Administration (FDA) from banning dietary products containing Ephedra.

State College pharmacies and nutrition stores have stopped selling Ephedra during the past year.

Ephedra, commonly used for bodybuilding, was popular for its weight-loss side effects. It was linked to 155 deaths and dozens more heart attacks and strokes in the United States.

Kevin Smith, clinical supervisor at the Mount Nittany Medical Center, said effects of Ephedra depend on an individual's medical history. Some people who use it have no side effects, he said. "It may not happen on 60 percent of the people, and then 10 percent can die. We just don't know," Smith said.

Patrick Fitzgerald, General Nutrition Center (GNC) spokesman, said GNC made the decision to discontinue dietary supplements containing Ephedra early in 2003, and by the end of June, all Ephedra-related products were taken off the shelves from all GNC stores. "It was really dictated by the overall business climate," he said. "There was an increasing consumer demand for Ephedra-free products."

Officials from NVE Pharmaceuticals Inc., which manufactured Stacker 2, said there is lack of proof to demonstrate Ephedra-related dangers.

The FDA maintains that the great number of scientific studies and reports is sufficient proof for the herb's stimulant-like effects.

Tom Miller, pharmacist at CVS Pharmacy, 116 W. College Ave., said CVS took dietary supplements containing Ephedra off the shelves about a year ago. "There were a lot of adverse effects, and then there was the pitcher from the Baltimore Orioles death. It's always been known that it could cause problems, but it took something as tragic as that to make it noticeable to the public," Miller said.

Baltimore Orioles pitcher Steve Bechler's Ephedra-related death on Feb. 17, 2003, caused a decrease in Ephedra sales and urged three states New York, Illinois and California to prohibit the stimulant on their own.

Research shows that the herb can speed up heart rate and constrict blood vessels, even in apparently healthy people. The greatest danger is for those suffering with heart disease and high blood pressure or those who engage in strenuous exercise.

Smith considered the nationwide ban a positive change because of the number of people with problems relating to Ephedra. "It can cause enough problems by not being completely controlled and on who gets it. It was either being banned completely or having very stringent guidelines to control it."

There are other herbs that can be used for dietary supplements that have no side effects, Smith said.

Dietary supplements are not as strictly regulated as medication, which has to be proved safe and effective before introducing it for sale. Federal law allows dietary supplements to be sold without having any such proof. To discontinue a dietary supplement, the law requires the FDA to show that it poses a significant health threat.

"Actual information about [Ephedra] should be published rather than having it banned. What people put into their bodies is their choice," Paige Richardson (junior-communications) said.

The FDA has been fighting manufacturers of dietary supplements containing Ephedra for a year, and in December 2003, it decided to ban the herb.

"I think it was wonderful that the [FDA] is starting to regulate drugs that are non-prescriptive. They're sold at nutritional centers for health, and they're probably the worst things you could take," Amanda Goldstein (junior-history and French) said.

Please note that you are not considered a client until you have signed a retainer agreement and your case has been accepted by us.Prior results do not guarantee or predict a similar outcome with respect to any future matter. | Attorney Advertising.